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AstraZeneca Q2 Oncology Sales Grow 14 Percent as Firm Awaits Key Precision Drug Regulatory Decisions


NEW YORK – AstraZeneca reported on Friday that its oncology revenues grew 14 percent in the second quarter, driven by sales of Tagrisso (osimertinib), Lynparza (olaparib), Imfinzi (durvalumab), and Enhertu (trastuzumab deruxtecan).

The firm's oncology drugs brought in $3.70 billion during Q2, accounting for over one-third of the UK-based drugmaker's $10.77 billion total revenue during the quarter, which was up 31 percent compared to $8.22 billion in the year-ago second quarter.

AstraZeneca leadership, pleased with the revenue growth, dedicated much time during a call on Friday updating investors on what to expect from its oncology portfolio in the second half of 2022 and through 2023. According to Susan Galbraith, AstraZeneca's executive VP of oncology R&D, the firm is expecting key regulatory decisions in the coming months, including the US Food and Drug Administration's decision to approve Enhertu — an antibody-drug conjugate that AstraZeneca sells with Daiichi Sankyo — for advanced HER2-low breast cancer patients based on data from the Phase III DESTINY-Breast04 clinical trial. Results from that trial received a standing ovation during the American Society of Clinical Oncology annual meeting last month.

The FDA granted both breakthrough therapy designation and priority review status to the application and is expected to make a regulatory decision during the fourth quarter of this year. AstraZeneca has also filed applications with the EU and Japanese regulators for the same indication.

Otherwise, Q2 2022 was a busy quarter in terms of regulatory action for Enhertu. In May, the FDA approved Enhertu as second-line treatment for advanced HER2-positive breast cancer, and the European Commission followed suit last month.

Although these new Enhertu approvals may have been too recent to have a major impact on Q2 sales of the antibody-drug conjugate, Dave Fredrickson, AstraZeneca's executive VP of oncology business, anticipated that the drug would continue to take market share from a competing drug, Genentech's Kadcyla (trastuzumab emtansine). "We've seen really brisk conversion in second-line [breast cancer] just two months after approval," Fredrickson said of Enhertu, adding that the firm now has penetrated 35 percent of the second-line HER2-positive breast cancer market.

"Just to put that into perspective, we saw Kadcyla a year ago have 45 to 50 percent use [in this setting], so the majority of that 35 percent [Enhertu] use that we're seeing in second-line is coming at the expense of Kadcyla."

Because AstraZeneca shares rights to Enhertu with Daiichi Sankyo, the firm reports the drug's growth in terms of collaboration revenue. In the second quarter, Enhertu brought in a share of gross profits for AstraZeneca that totaled $99 million, which was more than twice what it brought in during the first quarter of 2021.

"This [Enhertu] success unlocks further opportunity to utilize HER2-targeted therapies in HER2-low patients in breast cancer and beyond," Galbraith said.

Adjuvant treatments driving growth

Tagrisso, the firm's EGFR-targeted tyrosine kinase inhibitor for non-small cell lung cancer, was once again the firm's top-selling oncology drug. The drug brought in $1.40 billion for AstraZeneca during Q2, representing a 7 percent increase from Q2 2021. Growth was particularly strong in the US market, which Fredrickson chalked up to EGFR testing rates greater than 80 percent and strong momentum for the drug in the adjuvant treatment setting following FDA approval in late 2020. Worldwide, though, Fredrickson said, "there's still much work to do in terms of market education [about Tagrisso] and driving stage-shift for early disease."

AstraZeneca's immune checkpoint inhibitor Imfinzi and Lynparza both saw 15 percent sales growth this quarter versus the second quarter of 2021. Imfinzi brought in $695 million, and Lynparza brought in $673 million, due to greater use in the adjuvant breast cancer setting following the PARP inhibitor's US approval in BRCA-mutated breast cancer in early Q2.

New pipeline promise

Beyond the revenue growth in AstraZeneca's already approved oncology drugs, the firm is focusing efforts on several late-stage investigational agents in its pipeline, including its TROP2-directed antibody-drug conjugate datopotamab deruxtecan, or Dato-DXd, which AstraZeneca is again developing with Daiichi Sankyo in multiple solid cancers, including NSCLC and breast cancer. Just last month, the partners announced they'd begun dosing patients in the Phase III TROPION-Breast02 trial, pitting Dato-DXd against chemotherapy in advanced triple-negative breast cancer patients who aren't eligible to receive PD-1/PD-L1 immune checkpoint inhibitors.

During the second half of 2022, AstraZeneca is also anticipating a data readout from a Phase III study of its investigational AKT inhibitor capivasertib in first-line hormone receptor-positive, HER2-negative breast cancer. The firm is eyeing regulatory submissions for this drug in the first half of 2023, around when it also expects data readouts for the drug's benefit in TNBC.

The drugmaker also highlighted anticipated 2023 data readouts from a Phase III trial of its investigational drug camizestrant plus a CDK4/6 inhibitor for hormone receptor-positive, HER2-negative metastatic breast cancer patients with detectable ESR1 mutations.

The good and bad of the Medicare price negotiation bill

AstraZeneca and the entire drug industry are closely watching pending legislation that would give the US government the ability to negotiate Medicare drug pricing.

"The impact overall of Medicare Part D drug pricing reform is going to be overall quite manageable," said Fredrickson, acknowledging, however, that "there are going to be some impacts in oncology that are negative over the period." Beginning in 2027 and beyond, he said that there is a possibility that Tagrisso could be one of the drugs impacted by Medicare price setting. The list price for Tagrisso is over $17,000 per month. 

However, Fredrickson also pointed out that elements of the pending legislation could help Medicare patients better afford drugs like Tagrisso and other pricey treatments, which in turn could enable "greater adherence and compliance."